Medicament dispensing device

ABSTRACT

A medicament dispensing device for dispensing metered dosages of medicaments from a container. The device includes a container and an indicating device. The container has a first end and an opposite second end spaced from the first end along a longitudinal axis. The first end includes a valve stem extending longitudinally therefrom and moveable between a closed position and an open position. The container contains a plurality of metered dosages of medicaments, with the valve stem dispensing one of the plurality of metered dosages when the valve stem is moved to the open position. The second end has an end surface. The indicating device includes a housing and an indicator member disposed in the housing. The housing is mounted to the second end of the container with a bottom surface thereof disposed adjacent the end surface of the second end of the container. The housing and the second end of the container have substantially the same shape.

This application is a continuation of application Ser. No. 10/039,744,filed Oct. 26, 2001 U.S. Pat. No. 6,761,161, which is a continuation ofapplication Ser. No. 09/303,043, filed Apr. 30, 1999, now issued as U.S.Pat. No. 6,336,453, and which also is a continuation-in-part ofapplication Ser. No. 09/603,427, filed Jun. 26, 2000, now issued as U.S.Pat. No. 6,328,037, which is a continuation of application Ser. No.09/073,275, filed May 5, 1998, now issued as U.S. Pat. No. 6,082,358,the entire disclosures of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to an indicating device forindicating the number of metered dosages that have been dispensed from,or remain in, an aerosol container, and in particular, to an indicatingdevice adapted to be mounted to the aerosol container.

Aerosol dispensing devices have been developed that include a doseindicating device to indicate the number of metered doses that have beendispensed from the device, or to indicate the number of doses remainingtherein. For example, patients have certain conditions that can betreated with medicaments dispensed in an aerosol and administered to thepatient by inhalation. In one format, the aerosol with medicaments arecontained in a container, and dispensed in metered, or measured, dosageswith an inhalation device, or actuator boot. In such an arrangement, itcan be important for the patient to be able to ascertain the number ofmetered doses remaining in the container, either by an indication of thenumber remaining therein or by knowledge of the number already dispensedtherefrom, such that the patient is not caught unaware with an emptycontainer when in need of the medicament. Thus, it may be important forthe inhalation device to provide an accurate indication of either thenumber of doses remaining in the container, or the number of dosesalready dispensed therefrom.

Typically, a conventional aerosol container includes a body and a valvestem which can be depressed relative to the body so as to emit themetered dose of aerosol and medicament. The container typically issupplied with a predetermined number of metered doses, generally on theorder of about 200, such that the counting of the number of valve stemdepressions, and corresponding number of dispensed metered doses, can bedirectly correlated with the number of doses remaining in the container.

In operation, the container is typically received within a housing ofthe inhalation device, wherein the valve is brought into engagement witha support block in the housing. The user administers the medicament bymoving the container relative to the housing so as to depress the valvestem and internal valve and thereby release a metered dose, which istypically administered to the user through a port or mouthpieceextending from the housing. After the dose is administered, the valvestem, which is typically spring loaded, biases the container away fromthe support block so as to again move the container relative to thehousing. In this way, a metered dose of medicament is administered byeach cycle of linear reciprocal movement of the container relative tothe housing.

Some actuator boots, or other devices attached to the medicamentcontainer, have indicating devices that convert the linear reciprocalmovement of the container relative to the housing into a one-way, orsingle-cycle, movement of an indicator, wherein the indicator identifiesthe relative fullness of the container, the number of metered dosesremaining therein or the number of doses already administered. Althoughthese actuator boots with indicators, or separate indicator devices,have provided the advantage of generally being able to keep track of thenumber of dosages, there remains room for improvement. For example,indicating devices of this nature may include complex moving parts whichcan be difficult to assemble and expensive to manufacture. Such devicesmay also be susceptible to counting inaccuracies due to theconfiguration of the indexing or mating parts, or require excessiveamounts of space within the housing to accommodate the relatively largeor numerous moving parts. Others still may impede or interfere with theairflow and medicament being dispensed from the inhalation device.Alternatively, some devices use electrical circuitry to count or recordthe dispersements. Such devices can be relatively expensive tomanufacture, however, and typically require a power source which may besusceptible to damage in various environments, such as moist conditions.

SUMMARY OF THE INVENTION

Briefly stated, the invention is directed to an indicating device forindicating the number of metered doses that have been dispensed from orremain in a container. The container has a valve stem extendinglongitudinally therefrom; the valve stem being moveable between a closedposition and an open position. The container dispenses a metered dosagewhen the valve stem is moved to the open position. The indicating deviceincludes a base member adapted to be mounted to the container, a capmember moveably connected to the base member, an indicator memberrotatably mounted to the cap member and a drive member adapted to rotatethe indicator member an incremental amount upon a predetermined numberof axial movements of the cap member relative to the base member.

In a preferred embodiment, the cap member is moveable relative to thebase member along an axial path. The indicator member has a plurality ofteeth and is rotatably mounted to the cap member about an axissubstantially parallel to the axial movement of the cap member relativeto the base member. A drive mechanism, including the drive member,comprises a ratchet wheel rotatably mounted to one of the base memberand cap member about an axis substantially perpendicular to the axisdefined by the axial movement of the cap member relative to the basemember. The drive member is coaxially mounted with the ratchet wheel anda pawl is mounted to one of the cap member and base member. The pawl isselectively engaged with the ratchet wheel upon each axial movement ofthe cap member relative to the base member so as to rotate the ratchetwheel and drive member an incremental amount. The drive member isselectively engaged with at least one of the plurality of indicatormember teeth upon a predetermined number of axial movements of the capmember relative to the base member such that the indicator member isrotated an incremental amount.

In another aspect, the indicating device comprises a first and secondindicator member, with each of the first and second indicator membersmounted to the cap member about an axis substantially parallel to theaxial movement of the cap member relative to the base member. The firstindicator member selectively engages the second indicator member as thefirst indicator member completes a usage cycle, representing onecomplete use of the indicating device and attached container, so as torotate the second indicator member an incremental amount. In a preferredembodiment, the first indicator member comprises dosage indiciaindicating the number of doses that have been dispensed from or remainin the container, while the second indicator member comprises usageindicia indicating the number of usage cycles that have been completedfor the indicating device, or the number of usage cycles remainingtherefor.

In yet another aspect, the indicating device comprises a first indicatormounted to the cap member about an axis substantially parallel to theaxial movement of the cap member relative to the base member and asecond indicator member mounted to one of the cap member and the basemember about an axis substantially perpendicular to the axial movementof the cap member relative to the base member. In a preferredembodiment, both the first and second indicator members comprise dosageindicia indicating the number of doses that have been dispensed from orremain in the container, with the second indicator member rotating anincremental amount in response to each axial movement of the cap memberrelative to the base member and the second indicator member rotating anincremental amount upon a predetermined number of axial movements of thecap member relative to the base member.

In another aspect, the indicating device comprises a first and secondindicator member mounted to the cap member about an axis substantiallyparallel to the axial movement of the cap member relative to the basemember and a third indicator member mounted to the cap member about anaxis substantially perpendicular to the axial movement of the cap memberrelative to the base member. In a preferred embodiment, the first andthird indicator members comprise dosage indicia, while the secondindicator member preferably comprises usage indicia.

In yet another aspect, the indicating device comprises a reset memberconnected to one of the drive member and indicator member. The resetmember can be rotated to move the indicator member relative to the capmember independent of any axial movement of the cap member relative tothe base member.

In another aspect of the invention, a method is provided for indicatingthe number of measured dosages dispensed from or remaining in thecontainer. The method includes the steps of providing a housing formoveably supporting the container and providing an indicating devicehaving a cap member, a base member and an indicator member rotatablymounted to the cap member. The method further comprises the steps ofmoving the cap member toward the base member so as to move the containeralong the longitudinal axis and thereby move the valve stem to the openposition wherein a metered dosage is discharged, moving the cap memberaway from the base member, and moving the indicator member in responseto the movement of the cap member relative to the base member.

Referring to a preferred embodiment, the method further includes thesteps of engaging the ratchet wheel with the pawl upon one of themovements of the cap member toward and away from the base member andengaging the indicator member with the drive member so as to rotate theindicator member.

In yet another aspect, a method is provided for assembling a dispenserfor dispensing metered dosages of medicaments from a container. Themethod includes the steps of providing a housing, disposing a containerin the housing and mounting an indicating device to the container.

The present invention provides significant advantages over other aerosoldispensing devices and indicating devices used therewith. In particular,the indicating device can be separately manufactured and installed asneeded on any number of conventional types of aerosol containers withlittle or no required modification to the container or housing.Moreover, the indicating device with its indicator member and drivemechanism is comprised of a relatively few, simple mechanical parts thatare relatively easy to manufacture and assemble. In this way, theindicating device is made more robust and is less susceptible to damagewhen exposed to various adverse user environments. In addition, thedrive mechanism and indicator member provide a reliable indicatingdevice for indicating the number of doses dispensed from or remaining inthe container, and the indicating device can be made in a relativelycompact configuration that does not interfere with the use of thedispensing device.

The present invention, together with further objects and advantages,will be best understood by reference to the following detaileddescription taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an indicating device having a viewing window.

FIG. 1A is a top view of the indicating device showing an alternativeembodiment of the viewing window with indicia visible therethrough.

FIG. 1B is a top view of the indicating device showing an alternativeembodiment of the indicia.

FIG. 2 is a side view of the indicating device being mounted to the topof a container shown in cross-section.

FIG. 3 is a top perspective view of the indicating device with theviewing window positioned in the top of the cap member.

FIG. 3A is a top perspective view of the indicating device with theviewing window positioned along a side portion of the cap member.

FIG. 4 is a bottom perspective view of the cap member with the indicatormember mounted therein.

FIG. 5 is an exploded perspective view of the cap member and indicatormember shown in FIG. 4.

FIG. 6 is an exploded perspective view of an alternative embodiment ofthe indicating device, including a base member, a cap member, anindicator member, a ratchet wheel and drive member and a spring.

FIG. 7 is a bottom perspective view of the cap member and indicatormember of FIG. 6, with the indicator member mounted in the cap member.

FIG. 8 is an enlarged partial view of the indicator member and capmember of FIG. 7 showing an engagement of the indicator member by thecap member.

FIG. 9 is a bottom perspective assembly view of the cap member,indicator member, ratchet wheel, drive member and spring shown in FIG.6.

FIG. 10 is an exploded perspective view of the base member and the capmember with the drive mechanism and indicator member mounted therein.

FIG. 11 is a perspective assembly view of the indicating device shown inFIG. 10.

FIG. 12 is a cross-sectional view of the indicating device taken alongline 12—12 of FIG. 11, wherein the cap member is in a fully extendedposition relative to the base member prior to the application of anaxial force by the user.

FIG. 13 is a cross-sectional view of the indicating device similar toFIG. 12 but with the cap member shown as moving toward the base memberat an intermediate position of the stroke as indicated by thedirectional arrows.

FIG. 14 is a cross-sectional view of the indicating device similar toFIG. 12 but with the cap member reaching the bottom of the stroke asindicated by the directional arrows.

FIG. 15 is a cross-sectional view of the indicating device similar toFIG. 12 showing the cap member as it returns to the fully extendedposition relative to said base member as indicated by the directionalarrows.

FIG. 16 is a cross-sectional view of the indicating device taken throughthe middle of the indicating device and showing engagement membersdisposed in pockets formed in the base member.

FIG. 17 is a cross-sectional view of the indicating device taken throughthe middle of the indicating device and showing an alternative returnmechanism for the cap member.

FIG. 18 is a bottom view of the assembly of FIG. 9 (without the spring)at initial setting before a first actuation of the indicator device andcontainer.

FIG. 19 is a cross-sectional view taken along line 19—19 of FIG. 18.

FIG. 20 is a bottom view of the assembly of FIG. 9 (without the spring)after the ratchet wheel and drive member have completed one revolutioncorresponding to a predetermined number of actuations.

FIG. 21 is a cross-sectional view taken along line 21—21 of FIG. 20.

FIG. 22 is an enlarged partial bottom view of the cap member andindicator member showing the indicator member having an indexing memberengaging an indentation formed on the cap member.

FIG. 23 is a side view of an alternative embodiment of the indicatingdevice.

FIG. 24 is a top view of the indicating device shown in FIG. 23.

FIG. 25 is a cross-section view of the indicating device taken alongline 25—25 of FIG. 24.

FIG. 26 is a cross-section view of the indicating device taken alongline 26—26 of FIG. 23.

FIG. 27 is a perspective view of an indicating device with a resetdevice.

FIG. 28 is a perspective view of an indicating device with analternative embodiment of the reset device.

FIG. 29 is an exploded view of an alternative embodiment of theindicating device with an alternative embodiment of the reset device andan adapter.

FIG. 30 is a bottom perspective view of the indicating device andadapter shown in FIG. 29.

FIG. 31 is an exploded side view of an indicating device and adapterbeing applied to the bottom of a container supported in a dispenserhousing shown in cross-section.

FIG. 32 is a side view of an indicating device having an adapter appliedto the bottom of a container supported in a dispenser housing shown incross-section.

FIG. 33 is a side view of the indicator member and a lock member in adisengaged position.

FIG. 34 is a bottom view of the indicator member and lock member shownin FIG. 33.

FIG. 35 is a side view of the indicator member and lock member in anengaged position.

FIG. 36 is a bottom view of the indicator member and lock member shownin FIG. 35.

FIG. 37 is a perspective view of an alternative embodiment of anindicating device having at least one indicator member with dosageindicia and an indicator member with usage indicia.

FIG. 38 is an exploded perspective view of the indicating device shownin FIG. 37.

FIG. 39 is a bottom perspective view of the cap member shown in FIG. 38.

FIG. 40 is a bottom perspective view of a dosage indicator member shownin FIG. 38.

FIG. 41 is a top perspective view of a usage indicator member shown inFIG. 38.

FIG. 42 is a perspective view of a drive assembly and dosage indicatormember shown in FIG. 38.

FIG. 43 is a perspective view of the reset member shown in theindicating device shown in FIG. 38.

FIG. 44 is an exploded perspective view of an alternative embodiment ofan indicating device having indicator members with dosage indicia and anindicator member with usage indicia.

FIG. 45 is a bottom perspective view of the cap member shown in FIG. 44with a usage indicator member installed therein and a dosage indicatormember exploded out therefrom.

FIG. 46 is a bottom perspective view of a dosage indicator member shownin FIG. 44.

FIG. 47 is a perspective view of a reset assembly shown in FIG. 44.

FIG. 48 is a perspective view of the drive member shown in FIG. 44.

FIG. 49 is a bottom perspective view of the usage indicator member shownin FIG. 44.

FIG. 50 is a top perspective view of the usage indicator member shown inFIG. 44.

FIG. 51 is a bottom perspective view of the cap member shown in FIG. 44.

FIG. 52 is a cut-away perspective view of the reset member shown in FIG.44 with the drive member in a disengaged position.

FIG. 53 is a cut-away perspective view of the reset member shown in FIG.44 with the drive member in the engaged reset position.

FIG. 54 is a side view of a first and second dosage indicator memberwith the reset member and drive member in a disengaged position.

FIG. 55 is a side view of a first and second dosage indicator memberwith the reset member and drive member in an engaged reset position.

FIG. 56 is a top perspective view of a first and second dosage indicatormember, a usage indicator member and a drive assembly.

FIG. 57 is a bottom perspective view of the base member shown in FIG.38.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Referring to the drawings, and in particular FIGS. 31 and 32, an aerosoldispenser is shown as including a housing 200, or actuator boot, and acontainer 12 disposed therein. The housing has a longitudinallyextending cavity 202 shaped to receive the container. A top portion ofthe housing is generally open such that the container can be inserted inthe housing through opening 204 and be installed therein with a bottomend 14 of the container protruding from the housing so as to be exposedto the user for actuation.

The terms “longitudinal” and “axial” as used herein are intended toindicate the direction of the reciprocal movement of the containerrelative to the housing, and of an indicating device cap member relativeto a base member. The terms “top,” “bottom,” “upwardly” and “downwardly”are intended to indicate directions when viewing the inhalation devicesas shown in the Figures, but with the understanding that the containeris inverted such that the top surface thereof is located adjacent thebottom of the housing and vice versa. Moreover, it should be understoodthat a user can use the container and dispenser in any number ofpositions, including but not limited to the preferred upright positionshown in FIGS. 31 and 32.

As shown in FIGS. 31 and 32, a cylindrical support block 212 having awell 214 is formed in a bottom portion 206 of the housing. An orifice210 penetrates the support block to communicate with a bottom portion ofthe well. In one embodiment, a mouthpiece 208, intended for insertioninto the mouth of a patient, forms an exhaust port 216 that communicateswith the orifice and well. The mouthpiece 208 extends laterally from thehousing so as to facilitate insertion of the mouthpiece into the mouthof the patient.

The container 12 is cylindrical and has a hub 16 disposed on a topsurface 17 thereof. A valve stem 18 extends longitudinally from the hub.The valve stem extends coaxially from the container and is biasedoutwardly therefrom by a spring (not shown) mounted within the valvestem of the container. The container 12 is mounted in the housing bypress fitting the valve stem 18 in the well 214 of the support block.

In a preferred embodiment, the container 12 is filled with a pressurizedaerosol and medicament which is dispensed therefrom in specific metereddoses by depressing or moving the valve stem 18 from an extended closedposition to a depressed open position. A single metered dose isdispensed from the container by each reciprocal, longitudinal movementof the valve stem.

In operation, the opening of the valve stem is effected by moving thecontainer 12 reciprocally within the housing 200 along a longitudinalaxis, defined by the valve stem and the reciprocal movement of thecontainer, by depressing the bottom end 14 of the container relative tothe housing so as to move the valve stem 18 to the open position as itis supported within the well by the support block. As the valve stem ismoved to the open position, the container dispenses a metered dose ofaerosol and medicament through the well 214 and orifice 210. The aerosoland medicament are then transmitted to the patient through the exhaustport 216 of the mouthpiece by way of either a self-generated or assistedairflow.

In other delivery systems, the housing and holder for the container areattached to a component having a chamber with an output end. Examples ofthese kinds of delivery systems are shown for example in U.S. Pat. No.5,012,803, issued May 7, 1991, and U.S. Pat. No. 4,460,412, issued Sep.11, 1984, both of which are hereby incorporated herein by reference. (Nolicense, expressed or implied, is intended to be granted to either ofthese patents by reason of the incorporation by reference herein). Inthese kinds of delivery systems, the component having the chamber can beadapted to receive the mouthpiece of the housing, or it can beintegrally connected with a holder supporting the container. In eitherembodiment, the metered dose of medicament in aerosol is first dispensedfrom the container into the chamber, and thereafter inhaled by thepatient.

In a preferred embodiment, the container 12 is intended to dispense apredetermined number of metered doses of medicament. For example,conventional inhaler containers typically hold on the order of 100 to200 metered doses. It should be understood, however, that the range ofavailable doses could potentially vary from as few as one dose to asmany as 500, or even more, depending, for example, on the capacity ofthe container, and/or the size of the metering dose valve. In operation,it can be important for the patient to be aware of the number of metereddoses remaining in the container such that the patient is not caughtunaware with an empty container when in need of the medicament.

Now generally referring to the Figures, a dose indicating device isshown. The indicating device 10 indicates the number of metered dosesthat have been dispensed from or remain in the container. As shown inthe embodiments of FIGS. 1-3A and 10-11, respectively, the indicatingdevice 10, 200, 500 includes an indicating device housing comprised of acap member 20, 220, 520 disposed in a base member 40, 540. The basemember 40 is configured such that it can be mounted to the bottom of thecontainer 12. In a first embodiment, shown in FIGS. 2, 6 and 12-17, thebase member includes a convex, or curved bottom portion 50, or floor,which is shaped to be received in and to mate with the bottom end 14 ofthe container, which has a concave or inwardly curved contour (see FIG.2). The base member 40 is preferably bonded to the bottom of thecontainer with adhesive, double sided tape, or similar bonding agent. Asshown in FIGS. 6 and 10-15, a circumferential skirt member 94 extendsupwardly from the base portion to form a cavity 96.

Alternatively, as shown in FIG. 25, the base member 140 includes abottom portion 150, a downwardly depending circumferential skirt 152 andan upwardly depending circumferential skirt 156. Depending skirt 152forms a recess or cavity 154 which is shaped to receive the bottom endof the container. The base member is mounted on the container either bybonding one or more of the bottom portion or skirt to the container, orby press fitting the container in the cavity 154 so as to provide aninterference fit between the container and the depending skirt. Theupwardly depending skirt 156 and bottom portion form an upper cavity 158overlying the lower cavity 154.

In yet another embodiment, shown in FIGS. 29-32, an adapter member 90 isattached to one of the above-mentioned base members by way of bonding,an interference fit, a snap fit, or a threadable engagement. The adaptermember 90 preferably has a cylindrical configuration and comprises acircumferential skirt 92 that is shaped to receive the bottom end of thecontainer. Again, the adapter can be mounted to the container by way ofbonding, an interference fit, or both. Adapters having differentinternal diameters can be provided such that a single indicating devicehaving a modular base member can be mounted on various aerosolcontainers having a variety of outer diameters.

Alternatively, as shown in FIG. 57, the base member 1040 includes adownwardly depending circumferential skirt 1152 forming a recess 1154.The skirt 1152 includes one or more steps 1155 or shoulders, which formvarious inner diameters in the base member 1040. In this way, a singlebase member 1040 can be used with containers having different diameters.It should be understood that although only one step is shown, so as tothereby form two inner diameters on the skirt 1152, the base membercould be configured with additional steps so as to provide a pluralityof various inner diameters dimensioned to receive various containers byway of a friction fit. The skirt 1152 is also configured with aplurality of cut-outs, or slits 1153, which permit enhanced air flowaround the base member in embodiments where the base member may be inclose proximity to the area where the medicament or aerosol is beingdispensed.

Although the disclosed container and indicating device, and inparticular, the cap member and base member, are shown as preferablyhaving a circular cross section, those skilled in the art shouldunderstand that the container and indicating device, including anyadapter, can be configured in other shapes, including for example, butnot limited to, a rectangular or triangular cross-section.

As best shown in FIGS. 1, 1A and 1B, the cap member 20 has a top portion52 with a viewing window 34, 59 formed therein. Preferably, the capmember 20 is circular and the viewing window is formed in the topportion adjacent the outer periphery of the cap member so as to overlieindicia applied to the top of an indicator member supported beneath thecap member. The viewing window can be configured in a number of variousshapes. For example, the viewing window 34 can be tapered as shown inFIG. 1, or it can be an arcuate shaped window 59 bounded by coaxialinner and outer curved borders 57, 58 and radial side borders 56 asshown in FIGS. 1A and 1B. The top of the cap member preferably has aplurality of raised portions 54 forming a grippable pattern for theuser's thumb, or finger. In this way, the user can firmly press down onthe cap member without slippage. One of skill in the art shouldrecognize that other patterns or grippable surfaces, such as a knurledpattern, can be applied to the cap member to facilitate the use of theindicating device.

Referring to FIGS. 4, 6, 38 and 44 the cap member 20, 220, 1020, 2020comprises a circumferential skirt 92, 292, 1092, 2092 dependingdownwardly from the top portion 52, 252, 1052, 2052. The skirtpreferably has a smaller diameter than the upwardly depending skirt ofthe base member, such that the cap member skirt nests within theupwardly extending skirt of the base member. Alternatively, the capmember can be configured with a skirt having a larger diameter than theskirt of the base member such that the base member skirt nests in thecap member skirt. The cap member 20, 220, 1052, 2052 is moveably mountedto the base member 40, 1040, 2040 by way of a snap fit.

In particular, as shown in FIGS. 5, 6, 7, 9, 10, 16, 29 and 44 the capmember includes a plurality of engagement members 28, 228, 428 extendingfrom an outer circumferential surface of the skirt. The cap member 20,220, 420 is inserted axially within the recess or cavity 96 of the basemember such that the engagement members 28, 228, 428, which have atapered surface, slide past the rim 42 of the base member skirt untilthe engagement members are disposed in a plurality of pockets 43 formedalong the inner circumferential surface of the base member skirt to forma snap-lock fit. In particular, the upper surface of the engagementmember engages an engagement surface 45 defining the top of the pocket.In this way, the cap member is moveable with respect to the base memberalong an axial, or longitudinal, path. Alternatively, the rim of thebase member can be curved slightly inward such that the engagementmembers engage the inwardly curved rim portion so as to prevent the capmember from being separated from the base member.

The axial movement of the cap member 20, 220,1020, 2020 relative to thebase member 40 is bounded or constrained by the engagement of theengagement members with the top of the base member pockets (or the basemember rim) at a fully extended position and by engagement of a bottomrim 21, 221, 1021, 2021 of the cap member skirt with the upper surfaceof the bottom portion at the bottom of the stroke as shown for examplein FIGS. 12-15. One of skill in the art should understand that theengagement members can alternatively be formed on the base member skirtso as to engage pockets or openings, or a rim (or like protrusion),formed on the cap member skirt.

As shown in FIGS. 6, 9, 16 and 17, a spring 100 is disposed between thecap member and the base member. The spring is preferably disposed in adownwardly extending hub portion 30, 230 of the cap member (shown inFIGS. 4 and 6) and an upwardly extending hub portion 44 (shown in FIGS.10, 16 and 17) of the base member, which are received one in the other.Alternatively, as shown in FIG. 25, a spring 300 is disposed between thecap member and base member and is of such a size that the coils arepositioned adjacent the inner circumferential surface of the cap memberskirt 392. The spring 100, 300 functions as a return mechanism andbiases the cap member 60, 260, 360 upwardly in the base member such thatthe engagement members 28, 228 of the cap member engage the upperportion of the pockets of the base member. Although a compression springis shown in the Figures, it should be understood that a bellevillewasher, cantilever, torsion, leaf and/or tension springs would also workto bias the cap member upwardly into engagement with the base member.The springs can be made of metal or plastic.

As shown in FIGS. 4, 5, 16, 17 and 45, the return mechanism actingbetween the cap member and base member includes a plurality of resilientarm members 400, 2400 extending downwardly from the cap member. As thecap member is moved toward the base member, one or more of the armmembers engages a ramped biasing surface 402 formed along an outerportion of the hub portion 44. The ramped biasing surface biases one ormore of the resilient arm members outwardly as the cap member movestoward the base member. As shown in the embodiment of FIGS. 4 and 5, sixarm members 400 are arranged circumferentially around the hub portion30. Alternatively, as shown in the embodiment of FIG. 39, six armmembers 1400 are arranged in an “X” pattern around the hub 1030 so as toconserve space and provide additional room under the cap member 1020.Corresponding ramps, or ramped biasing surfaces are similarly arrangedin the base member 1140.

The resilient arm member(s) act as cantilever springs to bias the capmember away from the base member when the cap member is released by theuser. One of skill in the art should understand that the resilient armmembers can also be formed on the base member so as to engage a rampedsurface formed on the cap member. One of skill in the art should alsounderstand that the spring and resilient arm members can be usedtogether, as shown in FIGS. 16 and 17, or separately. In addition, itshould be understood that one or more arm members and/or ramps may beused, with the size and shape of the arm member and/or ramp membersbeing modified to provide more space between the cap member and basemember.

As shown in FIGS. 4, 6, and 44 a key member 32, 232, or alignment rib,extends radially from the cap member hub portion 30, 230. As shown inFIG. 10, a key hole 47, or slot, is formed in a radially extendingportion of the hub portion 44 of the base member. The slot extendsradially from the opening in the hub portion. During assembly, the keymember of the cap member is received in the key hole of the base memberso as to prevent rotation therebetween.

Referring to the various embodiments of FIGS. 4-9, 12-15, 38, 40, and44-46, a dosage indicator member 60, 260, 1060, 2060 is rotatablymounted in the cap member 20, 220, 1020, 2020 about an axissubstantially parallel to the axial movement of the cap member relativeto the base member. The indicator member is generally open in the middleand includes a top portion 76, 276, 1076, 2076 having an upper surface62, 262 that rotatably slides along a bottom surface of the top portionof the cap member. Alternatively, the indicator member can be mounted onthe outside of the cap member with a viewing window formed in theindicator member for viewing indicia applied to the top of the capmember.

As shown in the embodiments of FIGS. 5, 6, 38 and 44, the indicatormember 60, 260, 1060, 2060 includes a circumferential skirt 74, 274,1074, 2074 depending downwardly from the top portion. Referring to FIGS.5 and 8, a plurality of protrusions 26, 226, or engagement tab members,extend from an inner circumferential surface of the cap member skirt andengage a rim 64, 264 formed on the bottom of the indicator member skirt.Alternatively, the indicator member can include an engagement member, orrim, that engages a groove or similar opening in the cap member. In thisway, the indicator member is secured to the cap member so as to preventaxial movement therebetween but where the indicator member is permittedto rotate relative to the cap member. The indicator member is installedby snap-fitting the indicator member within the cap member. One of skillin the art should understand that the indicator member couldalternatively be rotatably mounted on the cap member hub portion (havinga portion of the key member cut away), or on a similar axle secured tothe cap member.

In yet another alternative embodiment, shown in FIGS. 25 and 26, a platemember 380 holds the indicator member 360 against the inner surface ofthe top portion of the cap member 320, wherein the spring 300 engages abottom surface of the plate member 380 to bias a top portion 398 of theplate member against the cap member 320 and the cap member away from thebase member. The indicator member 360 is nested in the recess formedbetween an outer flat portion of the plate member and the bottom surfaceof the cap member. Referring to FIG. 26, the drive assembly is mountedto the plate member 380 by inserting axle 384 through openings indownwardly extending walls 388 of the plate member. An enlarged portion396 on the end of the axle engages one of the walls, while the ratchetwheel 382 and drive member 386 are mounted to the other end of the axleto complete the assembly. A top portion of the plate member abuts thecap member.

As shown in the embodiments of FIGS. 4-9, 40 and 46 the indicator member60, 260, 1060, 2060 has a plurality of inwardly facing teeth 66, 266,1066, 2066 formed around the inner circumference of the skirt. As shownin FIGS. 5, 6, and 40, the teeth are preferably formed about only aportion of the circumference, such that a gap 1061 is formedtherebetween.

Alternatively, as shown in the embodiment of FIGS. 25 and 26, theindicator member 360 has a plurality of teeth 366 formed radiallyinwardly about an inner rim of an opening formed in the indicatormember, which is configured as a relatively flat ring that does notinclude a skirt. In yet another embodiment, shown in FIG. 29, theplurality of teeth 466 extend axially downwardly from a ring-likeindicator member 460.

As shown in the embodiments of FIGS. 5 and 44-46, the indicator member60, 2060 includes a plurality of indentations 68, 2068 formed about theouter circumferential surface of the skirt 74, 2074. The cap memberincludes a pair of upwardly extending resilient indexing members 22,2022 each having an end portion that engages one of the indentations soas to releasably engage the indicator member and prevent rotationtherebetween. The angular distance between the indentations 68, 2068 issubstantially the same as the angular distance between the plurality ofindicator member teeth 66, 2066. In this way, the indexing memberselectively engages the next indentation upon each incrementaladvancement of the indicator member defined by the distance betweenadjacent teeth. In the embodiment shown in FIG. 46, the indentations arepreferably formed as ratchet teeth which only permit one-way rotation ofthe indicator member 2060 relative to the cap member.

Alternatively, as shown in the embodiments of FIGS. 6 and 38-39, theindentations and indexing member are reversed, i.e., the indentations224, 1224 are formed about an inner circumferential surface of the capmember skirt and, and shown in FIG. 6, an indexing member 270 dependsdownwardly from the indicator member in a void formed in the skirt ofthe indicator member, or, as shown in FIG. 38, a pair of index members1270 are configured as flexible arms formed along a rim portion 1078along the bottom edge of the skirt 1074. In the embodiment shown inFIGS. 38, 39 and 40, the interaction between the index members 1270 andthe indentations 1224, which are preferably shaped as ratchet teeth,function to index the indicator member by holding it in place betweenactuations of the cap member and also to prevent the backward rotationof the indicator member 1060. It should be understood that one or moreindex members can be engaged with a plurality of indentations,preferably formed as ratchet teeth, to control the rotational movementof the indicator member, regardless of whether the index members orindentations are formed on the cap member or the indicator member.

In yet another alternative, shown in FIG. 26, the plate member 380includes a resilient indexing member 370 that engages one of theplurality of teeth 366 to selectively engage the indicator member so asto prevent the inadvertent rotation thereof. Alternatively, the indexingmember can extend from the cap member.

As shown in FIGS. 1A and 1B, dosage indicia 72, 172 in the form ofnumbers or color codings are provided on the top surface of theindicator member and are visible to the user through the viewing window34, 59 provided in the top of the cap member. Alternatively, as shown inthe embodiment of FIGS. 24 and 26, a zero is positioned adjacent arectangular viewing window 334, preferably by permanent etching, toindicate a multiplication by ten of the indicia visible in the viewingwindow. One and two digit indicia 372 are formed on the top of theindicator member 360 such that a three digit number is indicated to theuser.

In yet another alternative embodiment shown in FIG. 3A, the viewingwindow 534 is formed in an upper portion of the downwardly dependingcircumferential skirt 592 of the cap member. The indicia are applied tothe outer circumferential surface of the indicator member skirt 574 soas to be visible through the window. In this embodiment, a rim 542 ofthe base member is preferably scalloped in alignment with the viewingwindow 534 to provide an unobstructed view of the indicia and to informthe user as to the location of the viewing window.

One of the skill in the art should understand that other indiciaindicating the number of doses remaining in or dispensed from thecontainer would include, but not be limited to, various alpha-numericalcharacters, words, terms or phrases (such as “full” and “empty”),scales, grids, arrows, raised portions, indentations, color coding andsegmentation, shading and like markings, or any combination thereof. Forexample, a segmented color grid 172 displayed in the viewing window (asshown, e.g., in FIG. 1B) could turn from green, indicating a fullcontainer, to yellow, indicating an intermediate capacity, and finallyto red, indicating an empty container. It should also be understood thatthe indicia can be formed integrally with the counter member, or appliedthereto by means of paint, dye, etching, pad printing, hot stamping oradhesive labels. When using numerical indicia, the numbers can bearranged to go from 0 (or some beginning number) to the predeterminednumber of available doses such that a display of that number to the userindicates that the container is empty, or, conversely, to go from thestarting predetermined number to 0 (or some ending number), which againindicates to the user that the container is empty.

In a preferred embodiment, the indicator member is made of acrylonitrilebutadiene styrene (“ABS”), which is receptive to certain alternativeprocesses of printing or applying the indicia, including pad printingand hot stamping. The cap member and base member are preferably made ofa hard plastic material such as Acetel.

Referring to FIGS. 5-9 and 12-18, a drive mechanism is shown asincluding a drive assembly 80. The drive assembly includes a ratchetwheel 82 coaxially mounted to a drive member 86 on an axle 84. Theratchet wheel, drive member and axle can be made separately, with theratchet wheel and drive member then mounted on the axle, or all threeparts can be integrally molded as a one-piece component. The driveassembly is preferably made of hard plastic material such as Acetel.

In an alternative embodiment, shown in FIGS. 38 and 42, the driveassembly further includes a second dosage indicator member 1800coaxially mounted with and between the drive member 86 and ratchet wheel82. The indicator member 1800 is configured as a wheel and preferablyincludes dosage indicia positioned around the peripheral surface 1802thereof. Preferably, the indicia are comprised of consecutive numeralsrunning from 0 to 9.

In yet another alternative embodiment, shown in FIG. 44, the driveassembly includes a ratchet wheel 82 coaxially mounted with an indicatormember 1800. The drive member 86 is formed separately from the ratchetwheel and indicator member and includes a single tooth 89 that isdimensioned to be received in a groove 1801 formed in a collar 1082extending axially from the indicator member 1800. The tooth 89 of thedrive member 86 is received in the groove 1801 of the collar and can bemoved axially with respect to the collar, ratchet wheel and indicatormember.

The ratchet wheel 82 includes a plurality of teeth 88 (preferably ten)formed around its periphery. Each of the teeth includes an engagementsurface 89 and a tapered surface 87. As noted above, the drive member86, whether integrally formed with the ratchet wheel or separatelyconnected thereto, includes a single tooth 81 extending radially fromthe axle 84, or drive member collar.

In the embodiments shown in FIGS. 5, 6 and 45, the drive assembly ismounted to the cap member by engaging opposite ends of the axle 84 withdownwardly extending hub portions 36, 236, 2236 such that the axle,ratchet wheel and drive member rotate about an axis substantiallyperpendicular to the axial movement of the cap member relative to thebase member and to the axis of rotation of the indicator member.Alternatively, the drive assembly can be mounted to the base member in asimilar manner.

Alternatively, as shown in the embodiment of FIGS. 38-39, the axle 84 isreceived in a single hub 1036, or flexible snap enclosure rib. In thisembodiment, the drive assembly further includes a ramp 1083, which rampsup to a plurality of radially extending teeth 1085 formed around therotational axis of the drive assembly. A larger diameter axle 1084extends outwardly from the teeth. A reset member 1106 includes agrippable wheel portion 1107 and a collar 1109 that is dimensioned to bereceived in an laterally facing opening 1302 formed in the skirt of thecap member. A bearing support 1300 is formed around the periphery of theopening so as to provide support for the collar. The reset member 1106further includes four flexible, resilient fingers 1304 extending axiallyfrom the collar 1109. Each finger 1304 includes an engagement portion1306 extending radially inward from the end of the finger. Theengagement portion is shaped to engage one of the teeth 1085 formed onthe drive assembly. A protrusion 1308, or rib, is formed on one of thefingers so as to extend radially outward therefrom. The protrusion 1308acts as a drive portion and engages a downwardly depending protrusion1310 formed on the bottom of the indicator member adjacent the gap 1061formed between the teeth on the indicator member, as shown in FIG. 40.Preferably, the protrusion 1310 is positioned so as to be at the angularmidpoint between the two teeth spanning the gap.

As shown in FIGS. 12-15, the drive mechanism further includes a pawlmember 48, shown as a flexible rod or finger, which extends upwardlyfrom the bottom portion of the base member and selectively engages oneof the teeth of the ratchet wheel. Alternatively, the pawl member can bemoveably secured to the cap member and extend through the base member toengage the top of the container, such that the axial movement of the capmember toward the container causes the pawl to move toward the ratchetwheel and engage one of the teeth thereon as described below. Anon-return member 238, also shown as a flexible rod or finger, extendsdownwardly from the top portion of the cap member and selectivelyengages another of the teeth 88 of the ratchet wheel. It should beunderstood that the pawl member could alternatively extend from the capmember (and the non-return member from the base member) when the driveassembly is mounted to the base member, as described above.

In operation, as shown in FIGS. 12-21, the user depresses the cap 220member from a fully extended position (see FIG. 12) toward the basemember such that the cap member bottoms out in the base member at thebottom of the stroke (FIG. 14) and such that the base member imparts anaxial load on the container until a metered dosage is dispensedtherefrom. In a preferred embodiment, the biasing force of the spring100 (shown in FIG. 6), or alternative return mechanism such as theresilient arm members which act as springs, is less than the biasingforce of the spring located in the metering valve of the container, suchthat the cap member first bottoms out in the base member with thecontainer then being moved downwardly in the housing until a metereddose is dispensed.

Referring to FIGS. 12, 13 and 14, as the cap member 220 is depressedtoward the base member 40, the pawl 48 selectively engages theengagement surface 89 of one of the ratchet wheel teeth and rotates theratchet wheel. The tapered surface 87 of one of the teeth formed on theratchet wheel simultaneously biases the non-return member 238 outwardlyuntil it selectively engages the next tooth near the bottom of thestroke. The user then releases the cap member whereinafter the spring100 (shown in FIG. 6), or similar return mechanism, biases the capmember 220 away from the base member 40 until the engagement memberengages the base portion at the top of the stroke as shown in FIG. 15.When the cap member is released by the user, the container is biasedupwardly within the housing along the longitudinal axis such that thevalve stem is moved to the closed position within the container.Simultaneously, as the cap member is released and allowed to move awayfrom the base member, the pawl 48 is biased outwardly by the taperedsurface 87 of one of the teeth on the ratchet wheel as the non-returnmember 238 prevents a backwards rotation thereof so as to maintain aunidirectional rotation of the ratchet wheel. At the top of the stroke(shown in FIG. 15), the pawl 48 is again placed in position forselective engagement with one of the teeth of the ratchet wheel. In thisway, the ratchet wheel 82, and connected drive member 86 (shown in FIGS.18-21), are advanced an incremental amount for every actuation of thecontainer and the attendant release of medicament. The incrementalamount is defined by and dependent on the number of teeth formed aboutthe periphery of the ratchet wheel. When formed with ten teeth, as shownin the preferred embodiment, the ratchet wheel will make one fullrevolution for every ten actuations of the indicator device andcontainer, or a tenth of a revolution for each actuation. One skilled inthe art will appreciate that the ratchet wheel can be provided withvarious numbers of teeth formed about its periphery such that the moreor less axial movements or actuations of the container are required tomake one full rotation of the ratchet wheel.

Alternatively, the operation of the ratchet wheel can be reversed. Inthis embodiment, the pawl is biased outwardly by the tapered surface ofone of the ratchet wheel teeth on the downstroke. At the bottom of thestroke, the pawl is biased into engagement with one of the teeth. Whenthe cap member is released by the patient, the spring, or equivalentreturn mechanism, biases the cap member upwardly within the base memberalong the longitudinal axis such that the pawl member engages one of theteeth and thereby rotates the ratchet wheel an incremental amount. Inthis embodiment, the non-return member maintains the rotational positionof the ratchet wheel on the downstroke.

As shown in FIGS. 18-20, 38 and 44 the drive member 86 is shown aspreferably having a single tooth 81 or segment. Therefore, upon everytenth actuation, the drive member 86 is rotated such that the toothselectively engages one of the teeth 266 formed on the indicator memberso as to rotate the indicator member an incremental amount. Theincremental amount of rotation is defined by the distance betweenadjacent teeth, otherwise defined as the circular pitch of the teeth. Inthis way, the drive member is selectively engaged with at least one ofthe teeth of the indicator member after and upon a predetermined numberof axial movements of the cap member relative to the base member so asto rotate the indicator member the incremental amount. The predeterminednumber of axial movements required to cause the indicator member torotate is defined by and dependent upon the reduction ratio of theratchet wheel and drive member, which, in turn, is defined by dividingthe number of teeth formed on the ratchet wheel by the number of teethformed on the drive member. For example, as shown in the preferredembodiment, a ratchet wheel having ten teeth and a drive member havingone tooth will result in an incremental movement of the indicatormember, otherwise defined as the advancement of one tooth of theindicator member, upon every ten axial movements. Similarly, if thedrive member had four teeth, and the ratchet wheel twenty, thepredetermined number would equate to five axial movements, and so on. Aone-to-one gear ratio would result in a predetermined number of oneaxial movement, wherein the indicator member would be moved upon everyaxial movement.

Referring to FIG. 19, the indicator member 260 and drive member 86 areshown prior to an initial actuation or use by the user. In particular,the drive member tooth is positioned adjacent the first tooth 266 on theindicator member. In this embodiment, wherein the ratchet wheelcomprises ten teeth, ten actuations are required before the tooth 81engages the first tooth 266 on the indicator member as shown in FIG. 21.At this point, the indicator has completed a single cycle equal to thenumber of predetermined number of axial movements, which results orculminates in the incremental movement of the indicator member. Thecycle is then repeated (by again making the predetermined number ofaxial movements) so as to again culminate in the incremental movement ofthe indicator member. Preferably, as shown in FIGS. 1A, 3A, 24 and 26,numerical indicia (including numbers and dots) are applied in incrementsoften to correlate to the preferred embodiment requiring ten axialmovements for one incremental advancement of the indicator wheel.

The ratchet wheel and drive member with their reduction ratio provide asimple but reliable mechanism for advancing the indicator member. Inparticular, the indicator member can be made with fewer teeth than if itwere required to advance upon every actuation of the indicator memberand container. For ease of manufacturing, it is desirable to provide ascoarse a pitch on each of the indicator member and ratchet wheel aspossible, although the gears are still defined as fine-toothed gears.However, it is also intended that the indicator member make only asingle revolution (single-cycle) corresponding to a complete evacuationof medicament from the container. Thus, when a large number of doses (onthe order of 200 or more) are contained within the container, it isimportant for the ratchet wheel and drive member to provide a relativelyhigh reduction ratio, such that 200 linear reciprocal movements of thecap member and container correspond to one or less revolutions of theindicator member. As such, the indicator member can be made with coarserteeth at less cost. In addition, larger coarser teeth interacting with arelatively large drive member tooth helps to improve the accuracy of thedevice as those parts mesh. In addition, the mechanism, and itsattendant reduction ratio, permits the indicator member to make only asingle revolution during the life of the container, i.e., until it isemptied, even when the container contains a relatively large number ofmetered doses (on the order of 200 or more doses). This singlerevolution corresponds to a usage cycle, which is defined as themovement of the dosage indicator from an initial reading, whichindicates that the container is full, to a final reading, whichindicates that the container is empty. Of course, the indicator member,if initially set to a smaller number of dosages, may make less than acomplete revolution in completing a usage cycle.

In the alternative embodiments shown in FIGS. 38 and 44, the viewingwindow 1034, 2034 is large enough such that the first and second dosageindicator members 1060, 2060, 1800 with their indicia are visibletherein. In the operation of these embodiments, the indicator member1800 rotates with each actuation of the cap member 1020, 2020 relativeto the base member 1040, 2040 as the ratchet wheel 82 is driven by thepawl member. The indicator member 1800 rotates about an axissubstantially perpendicular to the axial movement of the cap memberrelative to the base member and to the rotational axis of the indicatormember 1060, 2060. In the preferred embodiment, with the indicatormember 1800 having “ones” indicia and the ratchet wheel 82 having tenteeth, the indicator member 1800 is advanced upon each actuation andprovides indicia visible to the user to notify them of such advancement.As the indicator member 1800 completes a cycle, or rotation, theindicator member 1060, 2060 is advanced one increment by the drivemember 86 and the indicator member 1800 begins another cycle. In thisway, the user is advised as to each actuation of the indicating deviceand the attendant dispensment of a dosage from the attached container.

Where, as shown in FIGS. 5 and 40, the teeth 66, 1066 extend onlypartially around the periphery of the indicator member, the indicatormember 60 1060 is not advanced after the drive member engages the lasttooth, even when the cap member is repeatedly moved to actuate thecontainer. This ensures that the indicator member cannot be advancedpast the last indicia indicating that the container is empty to a firstindicia indicating that the container is full, so as to confuse theuser.

Alternatively, as shown in FIGS. 33-36, the indicating device includes alock device. In particular, the base member includes a first lock member702, configured as a post member extending upwardly from the bottom ofthe base member. The indicator member 760 includes a second lock member704, shown in FIG. 35 as an extension of one of the plurality of teeth766 formed around the circumference of the indicator member. Inoperation, the cap member is moved towards and away from the base memberas described above so as to rotate the indicator member. During thisoperation, as shown in FIGS. 33 and 34, the first lock member 702 ispositioned inside the inner diametrical surface of the plurality ofteeth so as to not interfere therewith as it is moved into the recessformed by the indicator member as shown in FIG. 33. After the indicatormember has made one complete rotation, which preferably correlates to anemptying of the container, the second lock member 704 is rotated overthe first lock member 702 as shown in FIGS. 35 and 36. In this position,the cap member cannot be moved toward the base member and the user isthereby prevented from further discharging, or attempting to discharge,an empty container. The immobility of the cap member also provides asecondary indicia that the container is empty. One of skill in the artshould understand that the size and shape of the first and second lockmembers can be varied. For example, a post member may extend from thecap member so as to engage a stepped surface in the base member.

As shown in FIGS. 29 and 30, a reset wheel 106 is coaxially mounted withthe ratchet wheel 82 and drive member 86. The outer periphery 108 of thewheel, which includes a plurality of teeth for gripping by the user'sthumb, is exposed as it extends through the bottom surface 50 of thebase member. One of skill in the art should understand that the resetwheel can be exposed by extending from other portions of the indicatordevice for access by the user. The user rotates the reset wheel 106 tomanually rotate the indicator member to its original starting position,or any other desired setting, without having to move the cap memberrelative to the base member. In this way, the indicator member can berecycled for use on a new container, or can be moved to the propersetting prior to installing the indicating device on the container. Inthis way, the same indicating device can be used with various containerscontaining-varying numbers of metered dosages of medicament. During themovement of the indicator wheel relative to the cap member, the force ofthe indexing member against the indentations in one of the cap memberand indicator member is overcome such that the indexing memberrepeatedly moves into and out of engagement with the indentations as theindicator member is rotated by the user to the desired setting. Thismovement is similar to the movement of the indexing member occurringupon each incremental advancement of the indicator member relative tothe cap member.

Preferably, the reset wheel of FIGS. 29 and 30 is used with an indicatormember having teeth formed about its entire periphery, such that theindicator wheel need only be moved a few teeth (one or more) to returnit to the zero (or full, e.g., 200) position. The reset wheel can beused with or without the lock device described above, since the wheelcan be used to move or rotate the indicator wheel independent of anyaxial movement between the cap member and base member.

In an alternative embodiment shown in FIG. 28, a reset selector member602 is mounted to the end of the axle and is exposed in an opening 604in the side or skirt 694 of the base member. The reset selector member602 is mounted on the axle. The selector member 602 is provided with aslot adapted to receive the head of a screw driver or like tool, whichcan be actuated by the user to rotate the axle, coaxially mounted drivemember and indicator member until the desired indicia are visible in theviewing window. This feature can be valuable for resetting an indicatingdevice for use on a new container, or for initially setting the devicefor the proper number of doses contained in the container. One of skillin the art should understand that recesses and/or protrusions other thanthe disclosed slot can be exposed on the selector member to allow theuser to grip or otherwise operably engage the selector member and tothereafter rotate the indicator member. One of skill in the art shouldalso understand that the opening in the base member could be positionedanywhere along the longitudinal path of the axle as the cap member movesrelative to the base member so as to expose the selector member whenaligned with the opening.

In yet another alternative embodiment, shown in FIG. 27, a selectorwindow 806 is formed in the top of the cap member. A reset selectormember 802, configured as a protrusion or like grippable member, isexposed in the window as the indicator member is rotated to the emptyposition. In one embodiment, as described above, the plurality of teethare formed only around a portion of the periphery of the indicatormember so as to leave a gap between the first and last tooth. In such anembodiment, the selector window 806 is preferably of such length thatthe user can move the reset selector member 802 within the window untilthe first tooth is again in position for engagement with the drivemember. It should be understood, however, that the reset selector membercan also be used with an indicator member having teeth formed around theentire periphery of the member.

In an alternative embodiment, a plurality of reset members, or a similargrippable surface, configured for example as a plurality of notches orteeth, can be formed around the entire periphery of the indicator memberand exposed in a selector window, or alternatively, in the viewingwindow. In such an embodiment, the indicator wheel can be rotated toexpose different indicia at any time simply by engaging the resetselector members on the indicator member with the user's thumb or likemember.

In yet another embodiment, shown in FIG. 24, an opening, or selectorwindow 906, is provided in the top of the cap member. A thin tool, suchas a paper clip, is inserted through the opening to bias the resilientindexing member 370 out of engagement with the indicator member. Theuser can then operably engage the indicator member with their finger orthe like, either through the viewing window or a selector window, tomove the indicator member to the desired setting.

In yet another alternative embodiment, shown in FIG. 43, the resetmember, with the collar 1109 disposed on the axle 1084 of the driveassembly, is pulled axially outward with respect thereto from adisengaged position, where the engagement portions 1306 of the flexiblefingers 1304 are positioned circumferentially around the axle 84, to anengaged reset position, such that the engagement portions 1306 of theflexible fingers are biased outwardly as they ride up the ramp 1083 andare thereafter moved into engagement with the teeth 1085 formed aroundthe axle of the drive assembly. The user then rotates the reset member1106 about a rotation axis, which is substantially perpendicular to theaxial movement of the cap member relative to the base member. As thereset member is rotated, the protrusion 1308 on the flexible fingers isbrought into engagement with the protrusion 1310 on the indicator member1060 so as to rotate the indicator member an incremental amount andthereby bring the first tooth on the other side of the gap 1061 intoposition for engagement by the drive member, thus bridging the gap 1061between the teeth of the indicator member. As the reset member 1106 isfurther rotated, the drive member tooth 89 engages the teeth 1066 of theindicator member, and the reset member can be rotated to manually drivethe indicator member, or indicator members, to the desired presetcondition. For example, the indicator members can be reset to indicate200 dosages for use with a container having 200 dosages.

In a preferred embodiment, the engagement portions 1306 and/or teeth1085 formed on the axle of the drive assembly are configured to allowrotation of the drive member in only one direction. Therefore, rotationof the reset wheel in an opposite direction will not effect a rotationof the drive member in that same direction as the flexible fingers, withtheir engagement portions, will simply slide over the teeth formed aboutthe axle. This one-way rotation prevents the drive member from engagingand rotating the indicator member in an opposite direction, whichdirection is opposed both by the non-return member engaging the ratchetwheel, and the one-way indexing interface between the cap member andindicator member.

To install the reset member and drive assembly, the drive assembly isinstalled in a vertical manner such that the axle 84 is received in theflexible snap enclosure 1036. Once the drive assembly is snapped inplace, the reset member 1106 is inserted through the opening in the capmember and over the axle 1084 until the fingers eventually are disposedaround the axle 84 in the disengaged position. In this way, the resetmember, which is supported by the bearing surface 1300 of the capmember, further supports the drive assembly.

In yet another embodiment, best shown in FIGS. 52-55, the indicatormember 2060 has a plurality of teeth extending around the entirecircumference thereof. At least one of the teeth 2067 has a cut-awayportion 2069 aligned with the tooth 89 of the drive member. Accordingly,at the end of a cycle, the drive member is positioned in a disengagedposition where even repetitive actuations of the indicating device donot lead to the advancement of the indicator member as the drive member,with its one or more teeth 89, merely passes through the cut-awayportion 2069 of the tooth, with which it is aligned. In this embodiment,however, the drive member 86 is axially moveable with respect to theindicator member 1800 and ratchet wheel 82.

As best shown in FIGS. 44, 47 and 52-56, a reset member 2106 includes agrippable wheel 2107 connected to a drive shaft 2109. As shown in thepreferred embodiment of FIG. 47, the end of the drive shaft includes aplurality of teeth 2306, that engage slots 2308 or openings dimensionedto receive the teeth formed in one end of the drive member 86. The drivemember is installed on the shaft of the reset wheel such that the teeth2306 formed on the end thereof engage the slots 2308 formed in the drivemember. The drive member is then inserted into the groove 1801 of thecollar 1082 extending from the indicator member.

In operation, the user pulls the reset member 1206 axially outward so asto move axially the drive member 86 from a disengaged position, wherethe drive member tooth 89, or teeth, is aligned with the cut-awayportion 2069 of the tooth on the indicator member, to an engaged orreset position, where the drive member tooth is brought into engagementwith the portion 2067 of the tooth that is not cut-away. In the resetposition, the user rotates the reset wheel 2107 and connected drivemember 86 so as to advance the indicator member 2060, or indicatormembers, to the desired setting independent of the axial movement of thecap member relative to the base member. In the disengaged position, thereset wheel is recessed between a pair of tapered flanges formed aroundthe circumference of the base member.

As shown in FIGS. 44 and 52-56, the indicator member 2060 includes acover portion 2087 that extends radially inward from the top portion ofthe indicator member. The cover portion is brought into alignment withthe viewing window at the end of the usage cycle such that the indicator1800, which can continue to be spun beneath the cover portion is notvisible. Indicia, such as the number “0” or the words “end” or “empty”can be applied to the cover portion to inform the user that thecontainer is empty.

As shown in FIGS. 37-43, the indicating device also includes a usageindicator member 1500. The indicator member 1500 is configured as a ringand is disposed around the skirt 1074 of the dosage indicator member1060 where it is trapped between the rim flange 1078 of the indicatormember and the bottom surface of the top of the cap member. In this way,the usage indicator member 1500 is supported by and is moveable aboutthe dosage indicator member 1060. The indicator member 1500 also isthereby rotatably mounted about an axis substantially parallel to theaxial movement of the cap member relative to the base member. Theindicator member 1500, which is configured as a ring, has a plurality ofteeth 1502 formed around the outwardly facing radial periphery thereof.As the indicator member 1060 is advanced as explained above, a flexiblefinger 1273 formed along the circumferential rim 1078 of the indicatormember 1060 is biased radially inward by a ramp 1277 formed on theinside of the cap member so as to engage at least one of the pluralityof teeth 1502 formed on the indicator member and thereby advance theindicator member an incremental amount, defined by the distance betweenadjacent teeth. The number of teeth formed around the indicator membercorresponds to the number of intended usage cycles of the indicatingdevice.

In the preferred embodiment, which has only a single ramp 1277, theusage indicator member 1500 is advanced one tooth upon each completerotation of the dosage indicator member 1060, which corresponds to onecomplete usage cycle for the indicating device. For example, theindicating device can be initially set to reveal an initial count of 200dosages. As the indicating device is successively actuated to dispensethe dosages, the indicator members 1060, 1800, with indicia, areactuated to count down until they reveal a final count of 0 dosagesavailable for use. At that time, the drive assembly is positioned in thedisengaged position, as explained above.

As the reset member 1106 is used to actuate the drive assembly to resetthe device for another usage cycle, the indicator member 1060 with itsresilient finger 1273 is biased into engagement by the ramp 1277 suchthat the usage indicator member is rotated. In this way, the indicatormember 1500 is rotated, or advanced, upon the completion of eachsuccessive usage cycle. The number of teeth 1502 on the indicator member1500 corresponds to the number of intended uses for the indicator. Forexample, in the embodiment shown in FIGS. 38 and 41, the indicatormember 1500 has twelve teeth corresponding to an intended twelve uses ofthe indicating device with twelve different containers. As noted above,the reset member can be used to reset the indicia at any desiredreading, such that one indicating device can be used with successivecontainers having different numbers of dosages contained therein. Theindicator member 1500 also includes a stop member 1506 formed as aprotrusion that extends radially inward from the top of the indicatormember. The stop member 1506 engages a stop member (not shown) extendingdownwardly from the top portion of the cap member upon completion of thefinal predetermined usage cycle. This engagement prevents the user fromattempting to advance the dosage indicator member 1060 by way of thereset member and drive assembly, because the finger 1273 is biased intoengagement with at least one of the teeth on the usage indicator member,which is immobilized. In this way, the entire device is immobilized. Itshould be understood that although the preferred embodiment isconfigured for twelve usage cycles, the usage indicator member could beprovided with more or less teeth corresponding to more or less totalavailable usage cycles.

Referring to FIG. 41, the usage indicator member 1500 further includesan indexing member 1510 configured as a protrusion extending radiallyoutward from the outer circumferential surface of the indicator member.The indexing member 1510 selectively engages a plurality of teeth 1512formed around the inner circumferential surface of the skirt of the capmember. The indexing member 1510 and teeth 1512 are configured as aratchet to allow one-way rotation of the indicator member 1500 relativeto the cap member 1020. In a preferred embodiment, the indexing memberand teeth are tapered to interact and provide for the one-way action.

As shown in FIGS. 37 and 38, a plurality of viewing windows 1600 arearranged around the outer periphery of the top of the cap member. Aplurality of indicia 1602, shown as successive numbers, are affixed tothe top of the cap member adjacent the viewing windows. The upper edge1514 of the usage indicator member is provided with indicia that isvisible through the viewing windows 1600, such that the user canascertain which usage cycle the indicating device is currentlyfunctioning in. For example, in the embodiment shown in FIGS. 37 and 38,twelve viewing windows 1600 are provided with the numbers 1 to 12arranged adjacent thereto, which correspond to the 12 usage cyclesdefining the life of the indicating device. The numbers, or otherindicia such as various colors, can be applied to the cap member byprinting, molding or any other of the techniques described above.Alternatively, a single viewing window can be provided to expose theindicator member, whereupon indicia can be applied to the top surface orupper edge 1514 thereof, or, if the window is provided in the side ofthe cap member, along the outer circumferential surface thereof.

In the embodiment shown in FIGS. 44-45 and 49-51, the usage indicatormember 2500 includes a hub 2520 having an opening 2521 that is rotatablymounted on a post 2522 extending downwardly from the inner surface ofthe top portion of the cap member 2020. In this way, the usage indicatormember 2500 is rotatably mounted to the cap member 2020 about an axissubstantially parallel to and spaced from the rotational axis of thedosage indicator member 2060. The axis of rotation for the dosage usageindicator member is also substantially parallel to the axial movement ofthe cap member relative to the base member.

The indicator member 2500 includes a ring 2524 formed about the hub 2520which is connected thereto with a rib 2526 and a bottom surface 2528.The indicator member 2500 has a plurality of inwardly, radiallyextending teeth 2514 formed about the inner periphery of the ring, and aplurality of outwardly, radially extending teeth 2502 formed on thebottom surface of the indicator member around the outer peripherythereof. Both pluralities of teeth are configured as ratchet teeth toallow only for one-way rotation of the indicator member 2500.

Referring to FIG. 46, an engagement member 2573 extends from theindicator member 2060 and engages an engagement surface of one of theratchet teeth 2502 as the dosage indicator member 2060 completes onefull cycle. As the engagement member 2573 engages the engagement surfaceof one of the teeth 2502, the indicator member is rotated an incrementalamount.

Referring to FIG. 51, an indexing member 2577 extends downwardly fromthe cap member 2020 in a parallel and spaced apart relationship with thepost 2522. The indexing member 2577 is disposed in the space between thehub 2520 and the ring 2524 and selectively engages the inner teeth 2514formed around the inner periphery of the ring. Again, the indexingmember 2577 and teeth 2514 are preferably configured to allow for onlyone-way rotation of the usage indicator member 2500 relative to the capmember 2020. The number and angular spacing between the inner and outerteeth 2514, 2502 correspond such that the advancement of the indicatormember 2500 by way of engagement of the engagement member 2573 with oneof the outer 2502 teeth further advances the indexing member 2577 onetooth 2514 along the inner periphery of the ring. The predeterminednumber of usages for the indicating device corresponds to the number ofteeth formed around the inner periphery of the ring. After thecompletion of the final usage cycle, the indexing member 2577 is broughtinto engagement with the rib 2526, which functions as a stop member anddoes not permit the indicator member to be further rotated or advanced.At the same time, the engagement member 2573 is brought into engagementwith one of the teeth 2502 formed about the outer periphery of the ringsuch that the indicator member also cannot be advanced. In this way, thedevice is immobilized. Again, the indicating device can be provided witha predetermined number of inner and outer teeth, which corresponds tothe number of predetermined usage cycles for the indicating device.

The upper surface 2528 of the indicator member ring, which is preferablydomed, is provided with usage indicia to indicate the number of usagecycles completed or remaining for the indicating device. The usageindicia is visible to the user through a viewing window 2600 provided inthe cap member, as shown in FIG. 44. Again, the usage indicia can takethe form of various alphanumeric characters, colors or any of the othervarieties described above.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

1. A medicament dispensing device for dispensing metered dosages ofmedicaments from a container comprising: said container having a firstend and an opposite second end spaced from said first end along alongitudinal axis, said first end comprising a valve stem extendinglongitudinally therefrom and moveable between a closed position and anopen position, said container containing a plurality of metered dosagesof medicaments, said valve stem dispensing one of said plurality of saidmetered dosages when said valve stem is moved to the open position, saidsecond end having an end surface and said container having an outerperiphery at said second end, said outer periphery defining a firstcross-sectional shape of said second end in a first plane substantiallyperpendicular to said longitudinal axis; and an indicating devicecomprising a housing and an indicator member disposed in said housing,said housing mounted to said second end of said container and comprisinga bottom surface disposed adjacent said end surface of said second endof said container, and wherein said housing has an outermost peripherydefining a second cross-sectional shape of said housing in a secondplane substantially perpendicular to said longitudinal axis, whereinsaid outermost periphery of said housing is substantially identical tothe outer periphery of said second end and wherein no portion of saidindicating device extends outwardly beyond said outermost periphery ofsaid housing.
 2. The medicament dispensing device of claim 1 whereinsaid end surface and said bottom surface are each curved.
 3. Themedicament dispensing device of claim 2 wherein said end surface isconcave and said bottom surface is convex.
 4. The medicament dispensingdevice of claim 1 wherein said container comprises a cylinder andwherein said first cross-sectional shape is a first circle having afirst diameter, and wherein said second cross-sectional shape is asecond circle having a second diameter, wherein said first and seconddiameters are substantially identical.
 5. The medicament dispensingdevice of claim 1 wherein said housing comprises a base member definingsaid bottom surface and said outermost periphery of said housing and acap member moveably connected to said base member, said cap membermoveable relative to said base member along said longitudinal axis. 6.The medicament dispensing device of claim 5 wherein said indicatormember is rotatably mounted in said cap member about an axissubstantially parallel to said longitudinal axis.
 7. The medicamentdispensing device of claim 5 wherein said base member comprises a skirtdefining a cavity and said outermost periphery of said housing, andwherein at least a portion of said cap member is received in said cavityas said cap member is moved relative to said base member along saidlongitudinal axis.
 8. The medicament dispensing device of claim 1further comprising an actuator housing having a longitudinally extendingcavity and a well located at a bottom of said cavity, said actuatorhousing having a generally open end at a top of said cavity, and whereinsaid container is disposed in said cavity of said actuator housing withsaid valve stem inserted in said well, wherein said second end of saidcontainer with said indicating device mounted thereto extends from thegenerally open end of said actuator housing so as to be exposed to theuser, said container and said indicating device reciprocally moveablewithin said housing along said longitudinal extent of the cavity suchthat said valve stem is moved between said open and closed position byengagement with said well.
 9. The medicament dispensing device of claim1 wherein said housing is bonded to said second end of said container.10. A medicament dispensing device for dispensing metered dosages ofmedicaments from a container comprising: said container having a firstend and an opposite second end spaced from said first end along alongitudinal axis, said first end comprising a valve stem extendinglongitudinally therefrom and moveable between a closed position and anopen position, said container containing a plurality of metered dosagesof medicaments, said valve stem dispensing one of said plurality of saidmetered dosages when said valve stem is moved to the open position, saidcontainer comprising a first cylinder defining said second end, whereinsaid second end has an end surface and said first cylinder has a firstdiameter; and an indicating device comprising a housing and an indicatormember disposed in said housing, said housing comprising a secondcylinder having a bottom surface, wherein said housing is mounted tosaid second end of said container with said bottom surface disposedadjacent to said end surface of said second end of said container, andwherein said second cylinder has a second diameter, wherein said seconddiameter is not greater than said first diameter and wherein no portionof said indicating device extends laterally outwardly beyond said seconddiameter.
 11. The medicament dispensing device of claim 10 wherein saidfirst diameter is substantially the same as said second diameter. 12.The medicament dispensing device of claim 10 wherein said end surfaceand said bottom surface are each curved.
 13. The medicament dispensingdevice of claim 12 wherein said end surface is concave and said bottomsurface is convex.
 14. The medicament dispensing device of claim 10wherein said housing comprises a base member defining said secondcylinder and said bottom surface and a cap member moveably connected tosaid base member, said cap member moveable relative to said base memberalong said longitudinal axis.
 15. The medicament dispensing device ofclaim 14 wherein said indicator member is rotatably mounted in said capmember about an axis substantially parallel to said longitudinal axis.16. The medicament dispensing device of claim 14 wherein said basemember comprises a skirt defining said second cylinder and a cavityformed therein, and wherein at least a portion of said cap member isreceived in said cavity as said cap member is moved relative to saidbase member along said longitudinal axis.
 17. The medicament dispensingdevice of claim 10 further comprising an actuator housing having alongitudinally extending cavity and a well located at a bottom of saidcavity, said actuator housing having a generally open end at a top ofsaid cavity, and wherein said container is disposed in said cavity ofsaid actuator housing with said valve stem inserted in said well,wherein said second end of said container with said indicating devicemounted thereto extends from the generally open end of said actuatorhousing so as to be exposed to the user, said container and saidindicating device reciprocally moveable within said housing along saidlongitudinal extent of the cavity such that said valve stem is movedbetween said open and closed position by engagement with said well. 18.The medicament dispensing device of claim 10 wherein said housing isbonded to said second end of said container.
 19. A medicament dispensingdevice for dispensing metered dosages of medicaments from a containercomprising: an actuator housing having a longitudinally extending cavityand a well located at a bottom of said cavity, said actuator housinghaving a generally open end at a top of said cavity; said containerhaving a first end and an opposite second end spaced from said first endalong a longitudinal axis, said first end comprising a valve stemextending longitudinally therefrom and moveable between a closedposition and an open position, said container containing a plurality ofmetered dosages of medicaments, said valve stem dispensing one of saidplurality of said metered dosages when said valve stem is moved to theopen position, said container comprising a first cylinder defining saidsecond end, wherein said second end has an end surface and said firstcylinder has a first diameter; and an indicating device comprising ahousing and an indicator member disposed in said housing, said housingcomprising a second cylinder having a bottom surface, wherein saidhousing is mounted to said second end of said container with said bottomsurface disposed adjacent to said end surface of said second end of saidcontainer, and wherein said second cylinder has a second diameter,wherein said second diameter is substantially the same as said firstdiameter, and wherein no portion of said indicating device extendslaterally outwardly beyond said second diameter; wherein said containeris disposed in said cavity of said actuator housing with said valve steminserted in said well, wherein said second end of said container withsaid indicating device mounted thereto extends from the generally openend of said actuator housing so as to be exposed to the user, saidcontainer and said indicating device reciprocally moveable within saidhousing along said longitudinal extent of the cavity such that saidvalve stem is moved between said open and closed position by engagementwith said well.
 20. The medicament dispensing device of claim 19 whereinsaid end surface and said bottom surface are each curved.
 21. Themedicament dispensing device of claim 20 wherein said end surface isconcave and said bottom surface is convex.
 22. The medicament dispensingdevice of claim 20 wherein said housing comprises a base member definingsaid second cylinder and said bottom surface and a cap member moveablyconnected to said base member, said cap member moveable relative to saidbase member along said longitudinal axis.
 23. The medicament dispensingdevice of claim 22 wherein said indicator member is rotatably mounted insaid cap member about an axis substantially parallel to saidlongitudinal axis.
 24. The medicament dispensing device of claim 22wherein said base member comprises a skirt defining said second cylinderand a cavity formed therein, and wherein at least a portion of said capmember is received in said cavity as said cap member is moved relativeto said base member along said longitudinal axis.
 25. The medicamentdispensing device of claim 19 wherein said housing is bonded to saidsecond end of said container.